Fluid processing medical apparatus and method for setting-up a fluid processing medical apparatus

ABSTRACT

The invention relates to a method for setting up a fluid treatment apparatus using a single, and always accessible, reader of information relating to replaceable components which are to be mounted on the apparatus to perform the fluid treatment. It is also disclosed a fluid treatment apparatus having the always accessible reader. The reader can also be relied on to enter information other that those relating to the replaceable components, such as commands for the apparatus, patients&#39; related information, etcetera.

FIELD OF THE INVENTION

The invention relates to a fluid processing medical apparatus such as anextracorporeal blood treatment apparatus for performing one or more ofthe following treatments: ultrafiltration, hemodialysis,hemodiafiltration, hemofiltration, plasmapheresis, oxygenation, or otherprocedures on whole blood or on blood components, such as separation orcollection of blood or blood components. The invention also concerns amethod for setting-up a fluid processing medical apparatus.

BACKGROUND OF THE INVENTION

Blood processing apparatus such as extracorporeal blood treatmentmachines comprise a number of components which have a use limited intime or in the number of use cycles. In the present specification, thefollowing definitions assume the meaning below indicated:

-   -   disposables are those components which can be associate to the        processing apparatus for the duration of a single procedure or        treatment (i.e. single use components)    -   semi-disposables are those components which can be associate to        the processing apparatus for the duration of a limited number of        procedures or treatments (i.e. components designed to be used a        limited number of times).

Depending upon the situations, components such as filters(hemo-dialyzers, hemo-filters, ultrafilters and the like), solutionsbags, containers hosting liquids or powders for preparation of treatmentliquids, tubing sets, extracorporeal blood circuits, integrated modulesincluding a number of the components just mentioned could be used asdisposables or semi-disposables.

Before the medical apparatus, e.g. a blood treatment machine, has toexecute a treatment session, the operator shall setup the machine andinstall all appropriate disposable components suitable for running theselected treatment procedure. The operator also checks if one or moresemi-disposable components need to be changed.

Referring for instance to a blood treatment for treating patientssuffering from kidney failure, before any procedure starts the operatorshould normally install the filter, the bloodlines, the access devicesadequate for the treatment session. The operator also installs theappropriate concentrates and solutions to be used during the treatment,checks and/or changes the ultrafilters in the liquid preparation circuit(in case on-line liquid preparation is selected).

For the purpose of disclosure of the present invention disposables andsemi-disposable components are hereinafter globally referred to asreplaceable components.

As it can be easily understood the blood treatment apparatus shall beproperly instructed as to which specific replaceable components areinstalled because each component has specific properties which mayaffect the working of the apparatus and the direct or indirect deliveryto the patient of substances.

During the past years, in order to facilitate setup procedures, thosereplaceable components to be mounted on the treatment apparatus havebeen provided with indicia (such as bar codes, color codes, microchips,RFID devices, mechanical keys, etcetera) secured to the component anddetectable by a respective appropriate reader associated to thetreatment apparatus to provide the apparatus at least with aninformation relating to the identity of the same component.

Here below the technical solutions which the applicant regards asrelevant are described.

A first solution is disclosed in WO80-02376 which describes ahemodialysis system using disposables tubing and filter having opticalor magnetic coding indicia on a strip. The strip can be coded to match aspecific program or procedure, and the system can be constructed orprogrammed to generate a signal should the module and the program in thesystem not correspond.

U.S. Pat. No. 5,769,811 shows a blood processing machine and disposableunits for use therewith. The disposable units generally comprise acentrifuge bowl for separating whole blood into blood constituents, aninlet tube for conveying blood into the bowl, an outlet tube forconveying the blood constituents away from the bowl, and a manifold forplacing the inlet tube and the outlet tube in fluid communication with atube from a donor. The manifold has a machine-readable bar-code labelfor identifying to the blood processing machine which type of disposableunit is being coupled to it. The machine itself comprises a centralprocessing unit that controls overall operation, a first computer memorycontaining safety-monitoring instructions that cause the centralprocessing unit to monitor various state parameters in order to ensuredonor safety, and a second computer memory containing instructions thatdefine at least one apheresis or blood-processing protocol. In someimplementations, the second computer memory is removable from andinsertable into the blood processing machine by an operator.

U.S. Pat. No. 6,626,355 discloses a medical apparatus comprising anaccessory port and at least one accessory piece comprising a connectionelement complementary to said accessory port; the connection elementincludes a storage unit where coded and/or un-coded information isstored, is read by means of a readout unit disposed in the section ofsaid accessory port, and is compared to identification informationstored in readout unit; the medical device is activated when theidentification information match the desired identification information,and is blocked when the identification information do not match. Codedidentification information is de-codable by means of a proprietary key.

EP1170023 concerns a hemodialysis machine comprising at least onesemi-permanent component, such as an ultrafilter for use in the onlinepreparation of dialysis liquid. The component is changed periodicallyafter being used for several consecutive dialysis treatments; themachine comprises a bar-code reader for identifying the semi-permanentcomponents thus unequivocally identifying the semi-permanent componentmounted on the machine, and communicating its presence and identity tosaid control unit in the machine.

U.S. Pat. No. 6,685,831 discloses a dialysis machine with a device forpreparing dialysis solutions. Preparation of dialysis fluids ofdifferent concentrations is achieved by the fact that the device has adetector device, at least two connections and at least twointerchangeable storage containers to hold the solution ingredients tobe metered. Each container is connected to at least one connector, andthe connectors are connectable to the connections; the connectors or theareas of a connecting tube near the connectors have identification meanswhich can be detected by the detector device. It is also disclosed aconnector for connecting a storage container with solution ingredientsto a medical apparatus, where the connector or areas of a connectingtube near the connector has identification means. Detecting a connectionof a solution ingredient storage container is guaranteed by the factthat the connector is provided with identification means and is attachedto a matching component, and a reader unit determines the type andposition of the connector.

WO01/41831 discloses a hemofiltration machine including a chassis, atleast one flow controlling element on the chassis, and a controller forthe hemofiltration machine to operate the flow controlling element tocarry out a processing task in response to a control program, thecontroller including an input on the chassis for reading coded indicia,an extracorporeal circuit for circulating blood from an individualthrough a hemofilter, and a fluid processing cartridge holding theextracorporeal circuit for mounting as an integrated unit on the chassisin operating engagement with the flow controlling element and forremoval as an integrated unit from the chassis, the fluid processingcartridge carrying coded indicia incorporating a control program for thecontroller, the coded indicia being readable by the input in response tomounting the fluid processing cartridge on the chassis, to therebytransfer the control program to the controller for execution. DocumentWO2004033024 shows a medical-technical identification device foridentifying a sterile product for example a product intended forone-time-use only, when connected to a piece of medical equipment. Thesterile product includes a fixedly mounted information carrier which isadapted to deliver or to offer specific product information in acontactless fashion to a reading element connected to the equipment.

U.S. Pat. No. 5,658,456 describes a dialysis apparatus having adialysate preparation module and a tank for storing a dialysatesolution, for performing automatic verification of dialysate chemicalsprior to adding said chemicals to said dialysate preparation module soas to insure correct preparation of said dialysate solution, comprising:an electronic reader of a machine-readable indicator, said electronicreader incorporated into said dialysis machine; a bottle containing aunit batch of dialysate chemicals for treatment of a medical conditionof a patient to be treated by said dialysis machine, said bottle adaptedto be installed on an opening apparatus in said machine such that, whensaid bottle is opened, said dialysate chemicals are placed in fluidcommunication with said tank for delivery of said unit batch ofdialysate chemicals automatically into said tank; and a machine-readableindicator containing coded information (ID,LOT,DATE) as to saiddialysate chemicals contained in said bottle, said machine-readableindicator applied to said bottle in a manner for permitting machineidentification of the contents of said bottle by said electronic readerprior to operating the opening apparatus to open said bottle and addingsaid dialysate chemicals to said tank, whereby machine identification ofsaid dialysate chemicals contained in said bottle may occur prior tointroduction of said chemicals into said tank.

SUMMARY OF THE INVENTION

While numerous solutions have been provided, the applicant has envisageda new method and a new apparatus which are suitable for furtherimproving machine setup and data entry of information when replaceablecomponents are used.

Indeed, according to the technical solutions of the prior art, thetreatment apparatus had a respective reader located in correspondence ofthe position where the disposable or semi-disposable article is expectedto be mounted on.

This situation renders impossible accessing the reader while adisposable or semi-disposable is already installed.

Moreover in case a plurality of disposable or semi-disposable componentshave to be installed in different locations of the apparatus, then acorresponding number of readers would be required.

Furthermore the reader of replaceable devices ID according to the priorart is only used for a single purpose and cannot be relied on forentering commands or other data into the medical apparatus.

In view of this situation it is a goal of the present invention toprovide a fluid processing medical apparatus and method for transferringdata to a fluid processing medical apparatus capable of enhancing setupprocedures and, more in general, transfer of data to the medicalapparatus.

It is a further object of the invention to reduce the number of readersto be present on the medical apparatus side without impairing on theease and data entry reliability.

The above aims are reached by a method for setting-up a fluid processingmedical apparatus, the apparatus being of the type comprising:

a support structure for receiving a plurality of replaceable componentsof different categories in correspondence of respective operating areasof said apparatus, at least a user interface for enabling setting of aplurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, the method comprising thefollowing steps:

-   -   providing a reader having a reading portion for reading        information concerning the components, the reading portion being        distinct and spaced from said operating areas and accessible for        reading the information irrespective of the components being        engaged or not with apparatus,    -   reading the information of a new component to be installed on        the apparatus by relatively approaching the reading portion to a        carrier of said new component information,    -   coupling the new component with the apparatus in correspondence        of a respective of said operating areas, the component when        coupled leaving the reading portion accessible for reading the        information.

According to an aspect of the invention, after the reading step it isprovided a step of verifying if the new component is of the samecategory of a component already installed on the machine. In other wordsif for instance the new component is a concentrate container, such as abicarbonate cartridge, the method provides for checking if a bicarbonatecartridge was already installed on the apparatus. In practice theverifying step can be done by checking if a component having the samecategory of the new component has been already read before and/or bychecking if a component is engaged with the engaging means of the typeadapted to receive the new component.

The steps of reading and verifying can be repeated every time a newcomponent is to be coupled to the apparatus.

The replaceable components are a plurality of components of differentcategories (by way of non limiting example a plurality of filters, aplurality of concentrate cartridges, a plurality of bloodlines,etcetera), where each component of a same category having respectivemechanical connection to a corresponding operating area on theapparatus, different from that of components of other categories. Themedical apparatus includes a plurality of different types of engagingmeans, each type of engaging means being designed for mechanicallyengaging, in a respective operating area, a component of onecorresponding category only.

In an embodiment, the method includes the sequential steps of:

-   -   signaling that a component of the same category is already        installed on the apparatus    -   requesting for confirmation to substitute the installed        component with the new component,    -   initiating a procedure for substitution of the installed        component with the new component.

According to a further aspect of the invention, for instance beforecoupling each new component to the apparatus, the method provides for:

-   -   selecting a desired treatment procedure (for instance in case        the apparatus is a blood treatment machine, the method provides        for selecting among a plurality of treatments such as        hemofiltration, ultrafiltration, hemodiafiltration, hemodialysis        etcetera),    -   checking if the new component fits with the selected treatment        procedure,    -   signaling if the new component does not fit with the selected        treatment procedure.

While in one embodiment the information is fixed to the replaceablecomponent, the information carrier could also be the packaging of thecomponent or a card associated with the component.

According to a further aspect the reader can be relied on for enteringcommands into the apparatus by associating command information to areadable information carrier, relatively approaching to one another theinformation carrier and the reading portion to enter the command in theapparatus, initiating a treatment procedure complying with the enteredcommand.

According to another embodiment the reader can be relied on for enteringcommands into the apparatus by associating patient data information to areadable information carrier, relatively approaching to one another theinformation carrier and the reading portion to enter the command in theapparatus.

In addition to the above way of entering component related informationand initiating a substitution procedure of a replaceable component, themethod of the invention provides for an additional and parallelprocedure for installing a new replaceable component on the apparatuswithout interacting with said reader.

This additional procedure includes the following steps:

-   -   entering the information of a new component to be installed on        the apparatus by acting on said user interface,    -   verifying if the new component is of the same category of a        component already installed on the machine,    -   displaying on said screen a message informing if a component of        the same category is already installed,    -   in case a component of the same category is already installed        asking for confirmation to proceed with the substitution        thereof,    -   coupling the new component with the apparatus in correspondence        of a respective of said operating areas, the component when        coupled leaving the reading portion accessible for reading the        information.

In case a component of the same category is already present the methodcan also provide for the following steps: moving the installed componentfrom an operating condition to a non-operating condition where it can besafely disengaged from the apparatus, and then disengaging saidcomponent before installing the new one.

The step of entering information by acting on the user interfacecomprises the steps of:

-   -   Configuring the user interface as a plurality of displays, each        display being accessible to the operator and including        information corresponding to at least a respective replaceable        component (this can be done with a navigation keyboard or keypad        either part of the screen or external, which allows the user to        navigate through various displays stored in the memory of the        user interface control system),    -   Selecting the desired display of the user interface,    -   Selecting the new component to be installed by acting on said        selected display.

The user interface can also be used to enter commands without acting onsaid reader and/or to enter patient related information again withoutacting on said reader.

The above specified aims are also reached by a fluid processing medicalapparatus, comprising:

a support structure,

a plurality of replaceable components of different categories engaged tothe support structure in correspondence of respective operating areas,

at least a user interface enabling setting of a plurality of parameterspertinent to operation of said apparatus or pertinent to a process to beperformed by said apparatus, the user interface including at least ascreen,

-   -   a reader, distinct from said user interface, having a reading        portion for reading information concerning the components, the        reading portion being spaced from said operating areas and        accessible for reading the information irrespective of the        components being engaged or not to the support structure,

a control system for controlling operation of said medical apparatus andresponsive to actions by a user on said user interface, said controlsystem also communicating with the reader and being programmed forreceiving and storing at least said information concerning thecomponents every time the reader reads information concerning a newcomponent to be installed on the apparatus.

In practice the control system includes means for controlling theapparatus operation (a network of sensors, actuators and connections notfurther detailed as their nature is not relevant for the purpose ofpresent invention), means for receiving and storing information comingfrom and/or going to the user interface and means for receiving andstoring information coming from the reader (i.e. wired or wirelessconnections to the reader, a control processing unit of digital oranalogical type and a memory).

In one embodiment the control system is programmed (i.e. comprises meansin the form of an analogical circuit portion or in the form of asuitably programmed digital processor) for verifying if the newcomponent is of the same category of a component already installed onthe apparatus. The above steps of reading and verifying can beautomatically repeated anytime the reader reads information of a newcomponent to be installed. In one embodiment the step of verifyingincludes determining the category of the new component, and/or checkingif a component of the same category was detected before, and/or checkingif a component is engaged with the engaging means of the type adapted toreceive the components of the category of the new component.

The replaceable components are a plurality of components of differentcategories (by way of non limiting example a plurality of filters, aplurality of concentrate cartridges, a plurality of bloodlines,etcetera), where each component of a same category having respectivemechanical connection to a corresponding operating area on theapparatus, different from that of components of other categories. Themedical apparatus includes a plurality of different types of engagingmeans, each type of engaging means being designed for mechanicallyengaging, in a respective operating area, a component of onecorresponding category only.

According to one aspect of the invention, the control system is alsoprogrammed (i.e. comprises means in the form of an analogical circuitportion or in the form of a suitably programmed digital processor) forsequentially executing the following steps:

-   -   signaling that a component of the same category is already        installed on the apparatus,    -   requesting for confirmation to substitute the installed        component with the new component,    -   initiating a procedure for substitution of the installed        component with the new component.

In accordance with a further aspect of the invention, the control systemis programmed for executing the following steps:

-   -   receiving selection of a desired treatment procedure,    -   checking if the new component fits with the selected treatment        procedure,    -   signaling if the new component does not fit with the selected        treatment procedure,    -   allowing the step of coupling the new component with the        apparatus only after the step of checking if the new component        fits with the selected treatment procedure.

According to an embodiment of the invention, the information comprisesone or more selected in the group including:

-   -   Identity of the component,    -   Identity of a series of identical components (this can happen in        case a series of component shares same identical        characteristics),    -   Expiration date of the component,    -   Manufacturer,    -   One or more commands for programming the apparatus to execute a        procedure on said fluid,    -   Data concerning a patient (pressure measures made before        treatment, prescription, personal information)

The information carrier is one selected in the group comprising: asurface of the component, a packaging of the component, a cardassociated with the component.

The apparatus of the invention can also have the control systemprogrammed for receiving commands for carrying out a correspondingprocedure on said fluid and/or patient data by reading correspondinginformation associated to a readable information carrier which isapproached to the reading portion.

In addition to the reader, the control system can also be programmed forexecuting an additional procedure for installing a new replaceablecomponent on the apparatus without interacting with said reader, theadditional procedure comprising the steps of:

-   -   allowing to enter information of a new component to be installed        on the apparatus by acting on said user interface,    -   verifying if the new component is of the same category of a        component already installed on the machine,    -   displaying on said screen a message informing if a component of        the same category is already installed,    -   coupling the new component with the apparatus in correspondence        of a respective of said operating areas, the component when        coupled leaving the reading portion accessible for reading the        information.

The step of allowing entering information by acting on the userinterface can comprise the steps of:

-   -   Configuring the user interface as a plurality of displays, each        display being accessible to the operator and including        information corresponding to at least a respective replaceable        component,    -   Allowing selecting the desired display of the user interface,    -   Allowing selecting the new component to be installed by acting        on said selected display.

In practice the reader used in the invention can be any optical reader(bar code reader, or color code reader, or reader of any opticallydetectable shape and/or pattern) or a radio-frequency reader (RFIDreader) or magnetic reader (reader of magnetic strips) or any otherequivalent reader adapted to detect said information when the componentand the reading portion are approached one another (in contact or inproximity).

Further characteristics and advantages will better emerge from thefollowing description in relation to some preferred but non-limitingembodiments of the invention.

SHORT DESCRIPTION OF THE DRAWINGS

Referring now to the enclosed figures several methods and correspondingapparatus will be described with reference, again by way of non limitingexample, to replaceable components adopted in blood treatment apparatus.

The description will be made with reference to the figures of theaccompanying drawings, also provided by way of non-limiting example, inwhich:

FIG. 1 is a block diagram showing the steps of the main flow of processexecuted by the control system of the apparatus of FIG. 14 when thereader of the apparatus of FIG. 14 reads information concerning areplaceable component or concerning a command;

FIG. 2 a block diagram showing the process followed after the steps ofFIG. 1 by the control system of the apparatus of FIG. 14 when reading aconcentrate related information via the reader;

FIG. 3 is a block diagram showing the steps performed by a user forchanging a concentrate container using the apparatus of FIGS. 1, 2 and14;

FIGS. 4 and 5 show the process followed after the main flow of FIG. 1 bythe control unit of the apparatus of FIG. 14 when respectively adialyzer or a bloodlines code;

FIG. 6 is a block diagram showing the process followed control system18, after the main flow steps of FIG. 1, when a disinfection procedureis initiated upon a code of a disinfectant is read;

FIG. 7 is a block diagram showing the steps performed by a user forinitiating a disinfection procedure;

FIGS. 8-10 show the procedure followed by the control system 18 ofapparatus of the invention when using the reader for entering commands,such as by way of non limiting examples: DISINFECTION, RINSE or SERVICECOMMAND;

FIG. 11 a block diagram showing the steps performed by a user forinserting an event command when using the reader and when using the userinterface 30, and

FIGS. 12 and 13 are block diagrams showing the steps performed by thecontrol system after the main flow of FIG. 1 if respectively the code isneither recognized as a known replaceable component nor as a knowncommand;

FIG. 14 is a schematic view of the circuits of a blood treatmentapparatus provided with a reader for reading information relating toreplaceable components, according to the invention;

FIG. 15 is a schematic elevation of the blood treatment machine of FIG.14.

DETAILED DESCRIPTION OF NON-LIMITING EMBODIMENTS

With reference to the enclosed figures, reference numeral 1 indicates afluid processing medical apparatus according to an embodiment of thepresent invention.

The apparatus 1 of the non limiting embodiments herein described is anextracorporeal blood treatment machine for the treatment of pathologiessuch as kidney failure, liver failure, or congestive heart failure.While for sake of clarity and conciseness, the invention will beexplained in detail with reference to an extracorporeal blood treatmentmachine, the invention could find application in other fluid processingapparatuses such as machines for processing whole blood or bloodcomponents coming from a donor or from a source (such as one or morecontainers), machines for blood oxygenation, machines for the cleaningor purification of water for medical use, machines for the preparationof medical fluids, machines for the delivery of medical fluids (infusiondevices or drug administration machines), etcetera.

Going back to the embodiment of the attached figures, the apparatus 1 isan extracorporeal blood treatment machine able to perform one or more ofthe following extracorporeal blood treatments: ultrafiltration,dialysis, hemofiltration, and hemodiafiltration.

The apparatus 1 according to the embodiment of the drawings mainlycomprises:

-   -   A hydraulic circuit 2 for fresh treatment liquid, such as        dialysis liquid, which in use is to be sent into a first chamber        3 of a blood treatment unit, 4 and/or infusion liquid, which in        use is to be sent into the patient. The hydraulic circuit is        responsible for bringing the treatment liquid to the treatment        unit and/or directly to the patient with appropriate chemical        and physical properties. The hydraulic circuit is also        responsible for evacuating waste fluid from the blood treatment        unit.    -   A blood treatment unit 4 comprising at least a casing defining        at least two chambers 3, 5 separated by a semipermeable membrane        6.    -   Bloodlines 23, 25 connected to the second chamber of the blood        treatment unit.    -   A cabinet structure 32 housing the hydraulic circuit 2 and        supporting, during treatment, the treatment unit 4 and the        bloodlines 23, 25.    -   A user interface 30 which is typically mounted on a front panel        of the cabinet structure, but which could alternatively be in        the form of an independent unit, separate from the cabinet.

The circuit 2 includes at least a supply conduit 7, bringing dialysisliquid to the first chamber inlet, and a waste conduit 8, receivingspent liquid exiting via an outlet of the first chamber. One or moreconcentrate sources of concentrates could be present. The concentratesources could be designed to include containers for housing concentratedsolutions or dry concentrates. In the enclosed embodiment containers 9,10 deliver concentrated solutions, via respective lines 11, 12 and uponthe action of respective concentrate pumps 13, 14, into the conduit 7thereby properly mixing water coming from a source 15 with saidconcentrates and obtaining the dialysis liquid. In the machine of theenclosed embodiment one of the two containers, for instance container10, is a dry concentrate cartridge. While not shown in the drawings,cartridge 10 is also connected, upstream line 12, to a source of wateror of solution directly or indirectly coming from source 15.Conductivity or concentration sensors 16, 17 can be provided on conduit7 downstream each respective concentrate line. Said sensors providecontrol signals to a control system 18 which is responsible to act onthe concentrate pumps based on desired concentration settings and onsaid control signals. Sensors (not shown) detecting conductivity orconcentration of electrolytes can also be present on the waste conduit8. A pump 19 is generally operating on supply conduit 7 and a pump 20 onthe waste conduit 8. Of course different alternative embodiments can beenvisaged to bring dialysis liquid to the treatment unit withappropriate chemical and physical properties. For instance pre-prepareddialysis liquid bags or containers could be used, with no need of onlinepreparation of liquid from concentrates and water.

Fluid balance sensors, for instance a first and a second flow-meter 21,22, operating on the supply conduit 7 and on waste conduit 8respectively, are used and are connected to the control system toprovide signals necessary for regulating at least one of pumps 19, 20.Of course other fluid balance systems can be used: scales for instanceor balance chambers or any other volumetric or mass or flow-rate basedsystem available to the skilled man.

One or more ultrafilters could operate in the hydraulic circuit,upstream the treatment unit 4. For instance in the enclosed embodimentone ultrafilter 36 is present upstream concentrate line 11 and oneultrafilter 37 is placed downstream all concentrate lines 11 and 12.

The blood treatment unit 4 comprises at least a casing defining at leasttwo chambers 3, 5 separated by a semipermeable membrane 6. Theproperties and type of membrane can vary depending upon the patient'sneeds and type of treatment to be executed: in particular the treatmentunit could be an ultrafilter, an hemofilter, a dialyzer, anhemodiafilter, a plasmafilter etcetera.

The bloodlines 23, 25 connected to the second chamber of the bloodtreatment unit comprise an arterial branch 23, which in use serves towithdraw patient's blood to be treated, and a venous branch 25, which inuses serves to return treated blood to the patient.

The user interface 30 herein disclosed is connected with and part of themedical apparatus 1; however the user interface could be a self poweredunit with wired or wireless connection to the control unit of themedical apparatus.

The user interface 30 of the embodiment shown includes a screen 31, forinstance a touch screen, which allows interaction with the userinterface, for instance selection of certain parameters, visualization,either in analogical or in digital form, of values of said parametersand display of other information; of course depending upon the case theuser interface could include also buttons, knobs, or other hardwaremeans 31 positioned off the screen and operable to introduce entriesinto the control system.

The activity of the user interface is determined by control system 18,which is connected to the user interface, is responsive to actions by auser on said user interface, and controls operations of the medicalapparatus 1 by acting on a plurality of actuators (such as pumps 12, 13,19, 20, 27, valve 27 and others) and by receiving signals from aplurality of sensors (such as for instance sensors 12, 13, 21, 22, 29etc.).

The control system of presently shown embodiment includes a main controlunit, connected to the user interface 30, and at least a memoryconnected to the main control unit. From a technical point of view themain control unit includes at least a microprocessor, while theabove-mentioned memory can be in a single physical memory or inphysically separated memory devices. Of course other alternative couldbe equivalently adopted, such as a control system partly or totally ofanalogical type.

In extracorporeal blood treatment apparatus, as the one just described,as well in other medical apparatus some components are replaceable, inthe sense that they are replaced more or less frequently during the lifeof the apparatus, according to criteria which could vary depending uponthe patient, the specific component, the market where the component isused, etcetera. By way of non limiting example, referring to a dialysismachine for chronic treatment as the one just described, the dialyzer,the blood tubing set, the access devices, the infusion lines and bagsare replaced at the end of each treatment session or procedure. If arinsing and/or priming procedure is activated using fresh liquid comingfrom a bag the empty bag is typically disposed of at the end of theprocedure. The ultrafilters and concentrate containers used for thepreparation of treatment liquid can be changed at the end of eachtreatment session, or after a number of sessions, or after a number ofworking hours.

In conclusion, with reference to the blood treatment apparatus justdescribed, a number of components are replaceable components: theconcentrate containers 10, 11 (which can be in the form of deformablebags or rigid containers, containing concentrated either in liquid or insolid form), the bloodlines 23, 25, the blood treatment unit 4, theultrafilters 36, 37 in the dialysis preparation circuit, any infusionlines 38, the bags or other containers for the injection of fluids intothe blood circuit or into the blood lines, the access devices (needles,catheters, or the like).

As can be easily understood, the apparatus of the type described canhost and use a plurality of components of the same category: forinstance the same blood treatment apparatus can alternatively use anumber of different blood treatment units, or a number of alternativebloodlines, or a number of alternative concentrate containers etcetera.Typically before each treatment, an operator selects the needles,bloodlines, bags, dialyzer or other blood treatment unit, as well asother replaceable components ideal for that specific treatment. Theapparatus has engaging means differentiated per type of component: forinstance the ultrafilters located in the fluid preparation section ofthe hydraulic circuit present connectors positioned and shaped so thatthey cannot be engaged in place of the dialyzer; each component of thesame category presents respective mechanical connections to theapparatus different from those of the components of other categories, sothat each replaceable component fits with the respective connections onthe machine and setup mistakes on the part of the operator areminimized.

More precisely, the means for engaging replaceable components ofdifferent categories comprises a plurality of different types ofengaging means, each type of engaging means being designed for engaging,in a respective operating area, respective components of onecorresponding category only. Practically all concentrate containers ofthe same category (for instance all bicarbonate containers) haveidentical connectors and engage with corresponding ports suitably shapedon the apparatus: the cartridge 10 has for instance two opposedconnectors or ports 10 a, 10 b receivable in corresponding ports orconnectors 34 a, 34 b of the apparatus 1. Analogously all bloodlines aredesigned to engage corresponding seats on the apparatus, seats which arenot suitable for hosting the concentrate containers or other components.In the same manner all blood treatment units (hemofilters, dialyzers,hemodiafilters, etcetera) form another category and have connector orports designed to couple with a corresponding engaging means (which caninclude tubular ports and or counter-connectors other support mechanismsto hold in place the unit 4) on the support structure of the apparatus.

Before using the described apparatus, a user should prepare it for thespecific treatment to be delivered. The user should install allreplaceable components: put in place the bloodlines, the treatment unit,the various concentrate containers, substitute the ultrafilters ifnecessary, install all necessary bags and infusion lines. Then a primingprocess is started to clean, rinse and to remove air from all componentswhich are expected to enter in contact with blood or with treatmentliquid.

In view of this situation it is fundamental when setting the machine toinform the machine about the specific components that have been mountedas the procedures or treatments that the machine can deliver are ingeneral related to the components used. In order to enter setupinformation, the user can enter data of any kind relying on the userinterface: for instance, prescription data, treatment selectioninformation, and of course data relating to the components installed onthe machine.

As it will be explained in detail the user can navigate through thevarious levels or menus of the user interface 30 and select or enter theinformation corresponding to each replaceable component installed on themachine.

In order to facilitate the data entry process, a reader 35 is providedoperatively connected with the control system 18 and having a readingportion for reading information concerning the components. Eachreplaceable component is associated to a respective information; theinformation is borne by the respective component (i.e. on a label ordirectly on the component) or by the respective component packaging orby a card or other support; the nature of the reader is such that toread the information it is necessary approaching to one another thecomponent and the reading portion (depending upon the nature of thereader, which could be an optical reader such as a linear orbi-dimensional bar code reader, an radio based reader such as RFIDreader, a mechanical reader, or a reader of other nature, the user willneed to approach more or less the information support to the readingportion or even put reader and information support into contact). Inaccordance with one aspect of the invention the information carrier andthe reading portion should either be put into reciprocal contact orrelatively approached at a distance in the range of 30 cm or less.

The reader can be fixed to the apparatus support structure or be in theform of a movable reader connected to the apparatus control unit viawires or wireless.

In any case the reading portion of the reader is always operating in aposition distinct and spaced from said operating areas where thereplaceable components are expected to operate in use conditions. Inthis way, the reading portion is accessible for reading the informationirrespective of the components being engaged or not to the apparatus.

Going now to the specific embodiments of the attached figures, FIG. 1discloses in form of block diagram the steps followed by the controlsystem. As mentioned the control system can include a microprocessorbased control unit which is suitably programmed to execute the stepshere below disclosed. Alternatively the control system can be ananalogical system which is designed to carry out the steps as belowdescribed. In any case the control system by way of intrinsic design orby way of a suitable program includes means for performing the stepsbelow described.

While it will not be repeated for each step in below description it isintended that the control system is programmed for, or includes meansfor, performing each one of below steps. These means included in thecontrol systems can be suitably designed analogical circuit portions orprogrammed digital circuits of a control processing unit.

Referring to FIG. 1 the control system receives the scanned code, forinstance a barcode, from the reader 1 (step 100). The control systemcommunicating with the reader is programmed for receiving theinformation concerning the components: in practice, every time a newcomponent is approached to the reader (or the reader to support bearingthe component information) sufficiently for the reader to readinformation concerning a component to be installed on the apparatus,then said read out information is transferred to the control system 18.The control system then verifies if the syntax of the scanned codesatisfies predefined criteria (step 101) and in the negative generatesand error signal (which can be audible and/or displayed on the screen31), as per step 102.

The control system can also generate an acknowledgement message and/orsound, when on the other hand the barcode syntax is correct (step 103).

Then the control system verifies if the scanned code corresponds to acode of replaceable component (step 104) and in the affirmative decodesthe product number (step 105), for instance by comparing it with a listof numbers stored in the control system memory (step 107).

In the negative, the control system decodes the command number (step106), for instance by comparing it with a list of numbers stored in thecontrol system memory (step 108). In practice, depending as to whetherthe code corresponds to a component or to a command the control systemfollows one of the two branches of the diagram of FIG. 1.

If the control system has detected a code of a component, then theidentity of said component is searched in the library present in thecontrol system memory and first the category of the component isidentified (step 109) and a corresponding procedure initiated (step113); if a component category, is not identified a corresponding audibleand/or displayable signal is generated (step 110).

If the control system detects a command code, in step 111 the controlsystem verifies if the command is known or not. In the latter case aaudible and/or displayable signal is generated (step 112). If thecommand code is recognized as one of the known commands, the type ofcommand is detected (step 114) and a corresponding procedure initiated(step 115).

In case for instance the control system has detected a component codecorresponding to a concentrate, then the procedure and steps of FIG. 2is followed. If the control system has detected a component codecorresponding to a dialyzer, then the procedure and steps of FIG. 4 isfollowed. If the control system has detected a component codecorresponding to a bloodline, then the procedure and steps of FIG. 5 isfollowed. Of course component of other categories could be encompassedwith slightly different procedures followed by the control systemdepending upon the category of the component.

In FIG. 2, after the step 113, the control system verifies that thenumber is that of a concentrate, checks expiration date or othervalidity parameters (step 120), and warns accordingly the operatorthrough audible and/or visual signals (step 121). The control systemverifies then if the machine setup or configuration requires thedetected type of concentrate (step 122) and in the negative warnsaccordingly the operator through audible and/or visual signals (step123)

The control system also verifies the status of the apparatus in order todetect if the new component the code of which has been just read is ofthe same category of a component (same dry concentrate for instance)already installed on the machine (step 124). In the affirmative thecontrol unit is also programmed for signaling that a component of thesame category is already installed on the apparatus. If the control unitverifies that a component of the same category as the one read by thereader, then the control unit is programmed for requesting forconfirmation to substitute the installed component with the newcomponent (step 125). In case a conductivity calibration procedure isongoing the control system informs that it is not possible to take anyaction for the scanned concentrate (step 126). In case the concentrateis not valid, or not applicable in view of the apparatus selectedtreatment, or if a calibration or other momentary procedure preventingsubstitution of the specific component is ongoing, then the controlsystem returns to a condition where it is ready to receive a new barcode reading (step 127).

FIG. 4 and FIG. 5 flow diagrams are very similar to the above describeddiagram and procedure of FIG. 2, so the steps 120, 121, 122, 123executed by the control system will not be described again as the onlydifference is that in FIG. 4 a dialyzer code is detected and in FIG. 5 abloodlines code is detected. As to FIG. 4 it is however to be noted thatin case a dialyzer code is detected the control system verifies thestatus of the treatment procedure and if a dialyzer is already installed(step 124). Then it also verified if priming of the dialyzer currentlyinstalled is still running and if it has been completed or not (step126). Steps 125 and 127 are similar again to those of FIG. 2 for theconcentrate code. As to FIG. 5, after step 122 the control systemverifies if a bloodline is already installed on the machine and also ifblood has been already sensed by use for instance of a sensor (a sensorassociated with the bloodline and able to detect blood presence such asan optical sensor or a conductivity sensor or an electromagnetic sensoror a capacity sensor can be alternatively used. The sensor is incommunication with the control system). Steps 125 and 127 are similaragain to those of FIG. 2 for the concentrate code.

FIG. 6 diagram shows the procedure followed by the control system when athe code of a disinfectant replaceable component is detected. FIG. 6flow diagram is very similar to the above described diagram andprocedure of FIG. 2, so the steps 120, 121, 122, 123 executed by thecontrol system will not be described again as the only difference isthat in FIG. 6 a disinfectant code is detected. In FIG. 6 flow, afterstep 122 the step 124 of verifying the machine status includes verifyingif the blood treatment apparatus 1 is in one of the following operatingconditions:

-   -   priming status (step 130), i.e. a status where lines are washed        and rinsed before the treatment.    -   dialysis status (step 131), i.e. the true blood treatment,    -   disinfection status (step 132), i.e. disinfection of the circuit        2 after treatment.

If the apparatus is in one of the above conditions, then a step 133 isexecuted where the control systems generates a visible and/or audiblesignal warning the operator that a disinfection procedure of the bloodtreatment apparatus cannot be started.

Steps 125 and 127 of FIG. 6 are similar to those of FIG. 2, but for thefact that a disinfection confirmation is required and that afterconfirmation a disinfection procedure will start.

FIG. 8 diagram shows the procedure followed by the control system when acode of a command corresponding to a disinfection rinse profile isdetected a disinfectant replaceable component is detected. The controlsystem then verifies if the configuration of the machine is adapted torun the command (step 140). In the affirmative the control systemverifies if the machine status (step 141), which includes verifying ifthe blood treatment apparatus 1 is in one of the following operatingconditions:

-   -   priming status (step 142), i.e. a status where lines are washed        before the treatment.    -   dialysis status (step 143), i.e. the true blood treatment,    -   disinfection status (step 144), i.e. disinfection of the circuit        2 after treatment,    -   rinsing status (step 145), i.e. when the lines are rinsed after        a treatment.

If the apparatus is in one of the above conditions, then a step 146 isexecuted where the control systems generates a visible and/or audiblesignal warning the operator that a disinfection procedure of the bloodtreatment apparatus cannot be started.

Steps 125 and 127 of FIG. 8 are similar to those of FIG. 6.

FIG. 9 diagram shows the procedure followed by the control system when acode of a command corresponding to a request to go to a service screenor to perform a task is detected. The control system then verifies ifthe status of the machine is adapted to allow the command, i.e. toaccess to the status screen (step 150). In the affirmative the controlsystem loads on the user interface screen 31 the service screen andallows the operator to interact with it (step 151). If the command is atask, after step 150 the control system will let the operator to performthe task in question. If the check of step 150 is negative, then controlsystems generates a visible and/or audible signal warning the operatorthat the command is not applicable (step 152) and then the controlsystem returns to a condition where it is ready to receive a new barcode reading (step 127).

FIG. 10 diagram shows the procedure followed by the control system whena code of a command corresponding to an event that needs to be insertedis detected (events can be for instance: a medication given to thepatient, a patient problem that has been detected and so on). Thecontrol system then verifies if the status of the machine is adapted toreceive the event command (step 160). Then the control system comparesthe event command with a list of events stored in a library (step 161)and also checks the apparatus configuration (step 162). The controlsystem then verifies if for the entered event command a signature isnecessary or not (step 163). In the affirmative the signature is allowedto be entered (step 164) via an appropriate means (a touch screenportion can be used) and validated by comparing it with a signatureslibrary (step 165). In case of no validation the control system returnsto step 163. In case the signature is not mandatory (steps 166) or ifthe signature has been validated the control system moves to step 167where the event is recorded and inserted in a report table. In case asignature has not been inserted, but it is required for the event, thenthe control system returns to a condition where it is ready to receive anew bar code reading (step 168).

FIG. 12 diagram shows the procedure followed by the control system whena correctly formatted unknown code of a replaceable component is read.The control systems generates a visible and/or audible signal warningthe operator that the code is unknown (step 171) and then the controlsystem returns to a condition where it is ready to receive a new barcode reading (step 172).

FIG. 13 diagram shows the procedure followed by the control system whena correctly formatted unknown code of a command is read. The controlsystems generates a visible and/or audible signal warning the operatorthat the code is unknown (step 181) and then the control system returnsto a condition where it is ready to receive a new bar code reading (step182).

Going now to FIGS. 3, 7 and 11 comparatively showing the steps performedby a user when using the reader (right side of each figure) and whenusing the user interface 30 (left side), it is clear how advantageous idthe reader for entering commands and components identities. Of coursethe presence of the user interface which also allows to manually enterthe same commands and information in the control system gives redundancyand consequently high reliability.

The above steps subsequent to reading of a code can be basicallyrepeated by the control system every time the reader reads informationconcerning a component to be installed on the apparatus or a command tobe executed.

The above apparatus and method have been described assuming that thereading portion is always active, i.e. in a status where it is able toread information. While this could be the case, it is also alternativelypossible to have activation and de-activation of the reader and of thereading portion depending upon the following circumstances.

In particular, the control system of the apparatus 1 could be programmedfor receiving a information concerning a fluid treatment procedureselected by a user (by acting on the user interface for instance), andthen verifying if the selected fluid treatment procedure requires or notuse of the reading portion. For instance in case of a blood treatmentmachine after set up of the machine the machine can start theextracorporeal blood treatment. During such a treatment it is normallynot necessary to enter data using the reader and this latter can beconveniently turned off. The de-activation of the reading portion, whenthe selected treatment procedure does not require use of the readingportion, can be automatic (i.e. upon detection of the selection or ofthe start of the specific procedure) or commanded by the user acting onthe user interface (which can have an appropriate key or dedicatedarea). The control system can also be programmed for de-activating saidreading portion, when the reading portion reads no information during aprefixed timeout period.

The control system can also be programmed for verifying if the selectedfluid treatment procedure requires or not use of the reading portion andfor activating said reading portion, when the selected treatmentprocedure does require use of the reading portion.

In accordance with one embodiment the control system is programmed foractivating said reading portion, when the apparatus is turned on.

With the reference to the example of the enclosed drawings where theapparatus 1 is an extracorporeal treatment machine, the control systemcan be programmed—and thereby includes means—for executing one or moreof the following steps of detecting that:

-   -   a) a setup procedure has been selected or initiated (which could        include one or more steps of setting a prescription, preparing        the machine for treatment by engaging any replaceable components        with the machine, etcetera),    -   b) a blood treatment session has been initiated or that a        command to initiate a blood treatment procedure has been entered        through the user interface,    -   c) a blood treatment session has been concluded or that a        command to stop a blood treatment procedure has been entered        through the user interface,    -   d) a rinse back procedure has been initiated or that a command        to initiate a rinse back procedure has been entered through the        user interface.

The control system can be programmed—and thereby define means—forturning the reader on upon detection of a) or of c) or of d) and forturning the reader off, upon detection of b).

The medical apparatus 1 above described represents a non-limitingexample, which the present invention can be applied to. The apparatuscan of course include other components, which are not herein disclosed,as they are not relevant for the purpose of the understanding of presentinvention.

For instance when verifying the compliance of a component with aselected treatment procedure, this can be done in practice by relying onappropriate sensors of presence, such as mechanical switches orelectromagnetic sensors or optical sensors or equivalents thereof(operative in correspondence of the operating areas of the variouscomponents), or by means of indirect tests on the fluids interested oraffected by the presence of said components (for instance if aconcentrate container is present, then conductivity in the treatmentliquid is affected, if a dialyzer is present pressures in several partsof the circuit 2 and bloodlines are affected, if an ultrafilter ispresent again pressure sensing can be used).

1. Method for setting-up a fluid processing medical apparatus, theapparatus being of the type comprising: a support structure forreceiving a plurality of replaceable components of different categoriesin correspondence of respective operating areas of said apparatus, atleast a user interface for enabling setting of a plurality of parameterspertinent to operation of said apparatus or pertinent to a process to beperformed by said apparatus, the user interface including at least ascreen, the method comprising the following steps: providing a readerhaving a reading portion for reading information concerning thecomponents, the reading portion being distinct and spaced from saidoperating areas and accessible for reading the information irrespectiveof the components being engaged or not with apparatus, reading theinformation of a new component to be installed on the apparatus byrelatively approaching the reading portion to a carrier of said newcomponent information, coupling the new component with the apparatus incorrespondence of a respective of said operating areas, the componentwhen coupled leaving the reading portion accessible for reading theinformation, the method further comprising the steps of: selecting adesired treatment procedure, checking if the new component fits with theselected treatment procedure, signaling if the new component does notfit with the selected treatment procedure.
 2. Method according to claim1, wherein after the reading step it is provided a step of verifying ifthe new component is of the same category of a component alreadyinstalled on the apparatus.
 3. Method according to claim 2, comprisingthe step of signaling that a component of the same category is alreadyinstalled on the apparatus.
 4. Method according to claim 3, herein afterthe signaling step, the following steps are provided: requesting forconfirmation to substitute the installed component with the newcomponent, initiating a procedure for substitution of the installedcomponent with the new component.
 5. Method according to claim 4,wherein the above steps of selecting a desired treatment procedure,checking if the new component fits with the selected treatmentprocedure, and signaling if the new component does not fit with theselected treatment procedure are performed before the step of couplingthe new component with the apparatus.
 6. Method according to claim 2,the step of verifying comprises the steps of: determining the categoryof the new component, checking if a component of the same category wasdetected before, checking if a component is engaged with the engagingmeans of the type adapted to receive the components of the category ofthe new component.
 7. Method according to claim 2, the step of verifyingcomprises the steps of: determining the category of the new component,checking if a component is engaged with the engaging means of the typeadapted to receive the components of the category of the new component.8. Method according to claim 1, wherein said components comprise aplurality of components of different categories, each component of asame category having respective mechanical connection to a correspondingoperating area on the apparatus, different from that of components ofother categories.
 9. Method according to claim 8, wherein said apparatusincludes a plurality of different types of engaging means, each type ofengaging means being designed for mechanically engaging, in a respectiveoperating area, a component of one corresponding category only. 10.Method according to claim 1, wherein the above steps of reading andverifying are repeated for any new component to be installed.
 11. Methodaccording to claim 1, wherein the information comprises one or moreselected in the group including: Identity of the component, Identity ofa series of identical components, Expiration date of the component,Manufacturer, One or more commands for programming the apparatus toexecute a procedure on said fluid, Data concerning a patient.
 12. Methodaccording to claim 1, wherein the information carrier is one selected inthe group comprising: a surface of the component, a packaging of thecomponent, a card associated with the component.
 13. Method according toclaim 1, comprising the step of entering commands into the apparatus forcarrying out a corresponding procedure on said fluid, said step ofentering commands including the following sub-steps: Associating acommand information to a readable information carrier, Relativelyapproaching to one another the information carrier and the readingportion to enter the command in the apparatus, Initiating a treatmentprocedure complying with the entered command.
 14. Method according toclaim 1, comprising the step of entering patient data into theapparatus, said step of entering patient data including the followingsub-steps: Associating patient data information to a readableinformation carrier, Relatively approaching to one another theinformation carrier and the reading portion to enter the command in theapparatus.
 15. Method according to claim 1, comprising an additionalprocedure for installing a new replaceable component on the apparatuswithout interacting with said reader, said additional procedureincluding the following steps: entering the information of a newcomponent to be installed on the apparatus by acting on said userinterface, verifying if the new component is of the same category of acomponent already installed on the machine, displaying on said screen amessage informing if a component of the same category is alreadyinstalled, coupling the new component with the apparatus incorrespondence of a respective of said operating areas, the componentwhen coupled leaving the reading portion accessible for reading theinformation.
 16. Method according to claim 15, wherein said step ofentering information by acting on the user interface comprises the stepsof: a. Configuring the user interface as a plurality of displays, eachdisplay being accessible to the operator and including informationcorresponding to at least a respective replaceable component, b.Selecting the desired display of the user interface, c. Selecting thenew component to be installed by acting on said selected display. 17.Method according to claim 15, comprising a step of entering commandsusing said user interface and without acting on said reader.
 18. Methodaccording to claim 15, comprising a step of entering patient relatedinformation using said user interface and without acting on said reader.19. Method according to claim 1, wherein for reading the information,the carrier of said information is and the reading portion areapproached to a distance less then 30 cm.
 20. Method according to claim1, before the reading portion can read any information, a step isprovided for activation of said reading portion.
 21. Method according toclaim 1, after the reading portion has read any information, a step isprovided for de-activation of said reading portion.
 22. Method accordingto claim 1, wherein the reading portion is deactivated when at least oneof the following circumstances occurs: the reading portion reads noinformation for a prefixed timeout period, a user turns the readingportion off by acting of the user interface, a specific procedure notrequiring use of the reading portion is selected by the user, a specificprocedure not requiring use of the reading portion is initiated by theapparatus.
 23. Method according to claim 1, wherein the reading portionis activated when at least one of the following circumstances occurs:the apparatus is turned on, a user turns the reading portion on byacting on the user interface, a specific procedure requiring use of thereading portion is selected by the user, a specific procedure requiringuse of the reading portion is initiated by the apparatus.
 24. Fluidprocessing medical apparatus, comprising: a support structure, aplurality of replaceable components of different categories engaged tothe support structure in correspondence of respective operating areas,at least a user interface enabling setting of a plurality of parameterspertinent to operation of said apparatus or pertinent to a process to beperformed by said apparatus, the user interface including at least ascreen, a reader, distinct from said user interface, having a readingportion for reading information concerning the components, the readingportion being spaced from said operating areas and accessible forreading the information irrespective of the components being engaged ornot to the support structure, a control system for controlling operationof said medical apparatus and responsive to actions by a user on saiduser interface, said control system also communicating with the readerand being programmed for receiving and storing at least said informationconcerning the components every time the reader reads informationconcerning a new component to be installed on the apparatus, wherein thecontrol system is programmed for verifying if the new component is ofthe same category of a component already installed on the machine, andwherein the step of verifying comprises the steps of: determining thecategory of the new component, checking if a component of the samecategory was detected before, checking if a component is engaged withthe engaging means of the type adapted to receive the components of thecategory of the new component.
 25. Apparatus according to claim 24,wherein said components comprise a plurality of components of differentcategories, each component of a same category having respectivemechanical connection to a corresponding operating area on theapparatus, different from that of components of other categories. 26.Apparatus according to claim 25, wherein said apparatus includes aplurality of different types of engaging means, each type of engagingmeans being designed for mechanically engaging, in a respectiveoperating area, a component of one corresponding category only. 27.Apparatus according to claim 24, wherein the control system is alsoprogrammed for signaling that a component of the same category isalready installed on the apparatus.
 28. Apparatus according to claim 27,wherein the control system is programmed for executing the followingsteps, after the signaling step: requesting for confirmation tosubstitute the installed component with the new component, initiating aprocedure for substitution of the installed component with the newcomponent.
 29. Apparatus according to claim 24, wherein the controlsystem is programmed for executing the following steps: receivingselection of a desired treatment procedure, checking if the newcomponent fits with the selected treatment procedure, signaling if thenew component does not fit with the selected treatment procedure. 30.Apparatus according to claim 24, wherein the control system isprogrammed for repeating the above steps of reading and verifyinganytime the reader reads information of a new component to be installed.31. Apparatus according to claim 24, wherein the information comprisesone or more selected in the group including: Identity of the component,Identity of a series of identical components, Expiration date of thecomponent, Manufacturer, One or more commands for programming theapparatus to execute a procedure on said fluid, Data concerning apatient.
 32. Apparatus according to claim 24, wherein the informationcarrier is one selected in the group comprising: a surface of thecomponent, a packaging of the component, a card associated with thecomponent.
 33. Apparatus according to claim 24, wherein the controlsystem is programmed for receiving commands for carrying out acorresponding procedure on said fluid by reading a command informationassociated to a readable information carrier which is approached to thereading portion.
 34. Apparatus according to claim 24, wherein the readercomprises an optical reader or a radio-frequency reader adapted todetect said information when the component and the reading portion areapproached one another at a distance less then 30 cm.
 35. Apparatusaccording to claim 24, wherein the user interface comprises a means forreceiving an entry addressed to turn on or off the reading portion, saidcontrol system being programmed for: receiving said entry, andrespectively turning on or off the reading portion depending upon theentry.
 36. Apparatus according to claim 24, wherein the control systemis programmed for: receiving a information concerning a fluid treatmentprocedure selected by a user, verifying if the selected fluid treatmentprocedure requires or not use of the reading portion de-activating saidreading portion, when the selected treatment procedure does not requireuse of the reading portion.
 37. Apparatus according to claim 24, whereinthe control system is programmed for de-activating said reading portion,when the reading portion reads no information during a prefixed timeoutperiod.
 38. Apparatus according to claim 24, wherein the control systemis programmed for: receiving a information concerning a fluid treatmentprocedure selected by a user, verifying if the selected fluid treatmentprocedure requires or not use of the reading portion activating saidreading portion, when the selected treatment procedure does require useof the reading portion.
 39. Apparatus according to claim 24, wherein thecontrol system is programmed for activating said reading portion, whenthe apparatus is turned on.
 40. Method for setting-up a fluid processingmedical apparatus, the apparatus being of the type comprising: a supportstructure for receiving a plurality of replaceable components ofdifferent categories in correspondence of respective operating areas ofsaid apparatus, at least a user interface for enabling setting of aplurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, the method comprising thefollowing steps: providing a reader having a reading portion for readinginformation concerning the components, the reading portion beingdistinct and spaced from said operating areas and accessible for readingthe information irrespective of the components being engaged or not withapparatus, reading the information of a new component to be installed onthe apparatus by relatively approaching the reading portion to a carrierof said new component information, coupling the new component with theapparatus in correspondence of a respective of said operating areas, thecomponent when coupled leaving the reading portion accessible forreading the information, wherein after the reading step it is provided astep of verifying if the new component is of the same category of acomponent already installed on the apparatus, and wherein the step ofverifying comprises the steps of: determining the category of the newcomponent, checking if a component of the same category was detectedbefore, checking if a component is engaged with the engaging means ofthe type adapted to receive the components of the category of the newcomponent.
 41. Method for setting-up a fluid processing medicalapparatus, the apparatus being of the type comprising: a supportstructure for receiving a plurality of replaceable components ofdifferent categories in correspondence of respective operating areas ofsaid apparatus, at least a user interface for enabling setting of aplurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, the method comprising thefollowing steps: providing a reader having a reading portion for readinginformation concerning the components, the reading portion beingdistinct and spaced from said operating areas and accessible for readingthe information irrespective of the components being engaged or not withapparatus, reading the information of a new component to be installed onthe apparatus by relatively approaching the reading portion to a carrierof said new component information, coupling the new component with theapparatus in correspondence of a respective of said operating areas, thecomponent when coupled leaving the reading portion accessible forreading the information, the method further comprising the step ofentering commands into the apparatus for carrying out a correspondingprocedure on said fluid, said step of entering commands including thefollowing sub-steps: Associating a command information to a readableinformation carrier, Relatively approaching to one another theinformation carrier and the reading portion to enter the command in theapparatus, Initiating a treatment procedure complying with the enteredcommand.
 42. Method for setting-up a fluid processing medical apparatus,the apparatus being of the type comprising: a support structure forreceiving a plurality of replaceable components of different categoriesin correspondence of respective operating areas of said apparatus, atleast a user interface for enabling setting of a plurality of parameterspertinent to operation of said apparatus or pertinent to a process to beperformed by said apparatus, the user interface including at least ascreen, the method comprising the following steps: providing a readerhaving a reading portion for reading information concerning thecomponents, the reading portion being distinct and spaced from saidoperating areas and accessible for reading the information irrespectiveof the components being engaged or not with apparatus, reading theinformation of a new component to be installed on the apparatus byrelatively approaching the reading portion to a carrier of said newcomponent information, coupling the new component with the apparatus incorrespondence of a respective of said operating areas, the componentwhen coupled leaving the reading portion accessible for reading theinformation, the method further comprising the step of entering patientdata into the apparatus, said step of entering patient data includingthe following sub-steps: Associating patient data information to areadable information carrier, Relatively approaching to one another theinformation carrier and the reading portion to enter the command in theapparatus.
 43. Fluid processing medical apparatus, comprising: a supportstructure, a plurality of replaceable components of different categoriesengaged to the support structure in correspondence of respectiveoperating areas, at least a user interface enabling setting of aplurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, a reader, distinct from said userinterface, having a reading portion for reading information concerningthe components, the reading portion being spaced from said operatingareas and accessible for reading the information irrespective of thecomponents being engaged or not to the support structure, a controlsystem for controlling operation of said medical apparatus andresponsive to actions by a user on said user interface, said controlsystem also communicating with the reader and being programmed forreceiving and storing at least said information concerning thecomponents every time the reader reads information concerning a newcomponent to be installed on the apparatus, wherein the control systemis programmed for executing the following steps: receiving selection ofa desired treatment procedure, checking if the new component fits withthe selected treatment procedure, signaling if the new component doesnot fit with the selected treatment procedure.
 44. Apparatus accordingto claim 43, wherein the control system is programmed for allowing thestep of coupling the new component with the apparatus only after thestep of checking if the new component fits with the selected treatmentprocedure.
 45. Fluid processing medical apparatus, comprising: a supportstructure, a plurality of replaceable components of different categoriesengaged to the support structure in correspondence of respectiveoperating areas, at least a user interface enabling setting of aplurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, a reader, distinct from said userinterface, having a reading portion for reading information concerningthe components, the reading portion being spaced from said operatingareas and accessible for reading the information irrespective of thecomponents being engaged or not to the support structure, a controlsystem for controlling operation of said medical apparatus andresponsive to actions by a user on said user interface, said controlsystem also communicating with the reader and being programmed forreceiving and storing at least said information concerning thecomponents every time the reader reads information concerning a newcomponent to be installed on the apparatus, wherein the control systemis programmed for receiving commands for carrying out a correspondingprocedure on said fluid by reading a command information associated to areadable information carrier which is approached to the reading portion.46. Apparatus according to claim 45, wherein the control system isprogrammed for receiving patient data by reading data carried by areadable information carrier which is approached to the reading portion.47. Apparatus according to claim 46, wherein the control system isprogrammed for executing an additional procedure for installing a newreplaceable component on the apparatus without interacting with saidreader, the additional procedure comprising the steps of: allowing toenter information of a new component to be installed on the apparatus byacting on said user interface, verifying if the new component is of thesame category of a component already installed on the machine,displaying on said screen a message informing if a component of the samecategory is already installed, coupling the new component with theapparatus in correspondence of a respective of said operating areas, thecomponent when coupled leaving the reading portion accessible forreading the information.
 48. Apparatus according to claim 47, whereinsaid step of allowing entering information by acting on the userinterface comprises the steps of: Configuring the user interface as aplurality of displays, each display being accessible to the operator andincluding information corresponding to at least a respective replaceablecomponent, Allowing selecting the desired display of the user interface,Allowing selecting the new component to be installed by acting on saidselected display.
 49. Fluid processing medical apparatus, comprising: asupport structure, a plurality of replaceable components of differentcategories engaged to the support structure in correspondence ofrespective operating areas, at least a user interface enabling settingof a plurality of parameters pertinent to operation of said apparatus orpertinent to a process to be performed by said apparatus, the userinterface including at least a screen, a reader, distinct from said userinterface, having a reading portion for reading information concerningthe components, the reading portion being spaced from said operatingareas and accessible for reading the information irrespective of thecomponents being engaged or not to the support structure, a controlsystem for controlling operation of said medical apparatus andresponsive to actions by a user on said user interface, said controlsystem also communicating with the reader and being programmed forreceiving and storing at least said information concerning thecomponents every time the reader reads information concerning a newcomponent to be installed on the apparatus, wherein the control systemis programmed for: receiving a information concerning a fluid treatmentprocedure selected by a user, verifying if the selected fluid treatmentprocedure requires or not use of the reading portion de-activating saidreading portion, when the selected treatment procedure does not requireuse of the reading portion.
 50. Fluid processing medical apparatus,comprising: a support structure, a plurality of replaceable componentsof different categories engaged to the support structure incorrespondence of respective operating areas, at least a user interfaceenabling setting of a plurality of parameters pertinent to operation ofsaid apparatus or pertinent to a process to be performed by saidapparatus, the user interface including at least a screen, a reader,distinct from said user interface, having a reading portion for readinginformation concerning the components, the reading portion being spacedfrom said operating areas and accessible for reading the informationirrespective of the components being engaged or not to the supportstructure, a control system for controlling operation of said medicalapparatus and responsive to actions by a user on said user interface,said control system also communicating with the reader and beingprogrammed for receiving and storing at least said informationconcerning the components every time the reader reads informationconcerning a new component to be installed on the apparatus, wherein thecontrol system is programmed for: receiving a information concerning afluid treatment procedure selected by a user, verifying if the selectedfluid treatment procedure requires or not use of the reading portionactivating said reading portion, when the selected treatment proceduredoes require use of the reading portion.